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Varenicline in Spinocerebellar Ataxia Type 3
NCT00992771Phase 2
Key facts
- Status
- Completed
- Start
- Oct 2009
- Primary completion
- Apr 2011
- Countries
- 1
- Sponsor
- University of South Florida
- Drugs
- varenicline
- Conditions
- spinocerebellar ataxia type 3 (SCA3)
01
Overview
Phase 2, randomised, double-blind trial in spinocerebellar ataxia type 3 (SCA3) comparing Varenicline with Placebo (2 arms). Primary endpoints: Scale for the Assessment and Rating of Ataxia at 25 weeks and Frequency and severity of dose-limiting adverse events at 25 weeks. Started Oct 2009; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Varenicline
Varenicline up to 1mg BID for 8 weeks
Placebo
Placebo matching varenicline for 8 weeks
03
Who it enrols
Adult outpatients (18-80) with genetically confirmed SCA3, SARA score >= 10, and gait score >= 3, excluding those with unstable medical conditions, psychiatric disorders, or recent smoking history.
04
Endpoints
Primary
Scale for the Assessment and Rating of Ataxia
Frequency and severity of dose-limiting adverse events
Secondary
Quality of Life
Depression and Anxiety Ratings
Activities of Daily Living
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